NCT06349408 · Fortvita Biologics (USA)Inc.
IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
What this study is about
This is a Phase 1 conducted at multiple hospitals, multi-regional, where both patients and doctors know the treatment given, first-in-human study of IBI3001 in participants with unresectable, locally advanced or metastatic solid tumors. The purpose of this study is to identify the MTD/RP2D of IBI3001, and to explore the preliminary effectiveness of IBI3001.
View original scientific description
This is a Phase 1 multicenter, multi-regional, open-label, first-in-human study of IBI3001 in participants with unresectable, locally advanced or metastatic solid tumors. The purpose of this study is to identify the MTD/RP2D of IBI3001, and to explore the preliminary efficacy of IBI3001.
Interventions
DRUG
IBI3001
The provisional dose levels are planned to be evaluated, but it is possible for additional and/or intermediate dose levels to be added during the study. IBI3001 is proposed to be administered by intravenous infusion (IV)
Primary outcome measures
Number of subjects with adverse events
Time frame: 24 months
Occurrence and severity of adverse events (AEs), with severity determined by NCI CTCAE v5.0 criteria
Number of subjects with clinically significant changes in physical examination results
Time frame: 24 months
Clinically significant abnormal physical examination findings reported by the investigator.
Number of subjects with clinically significant changes in vital signs
Time frame: 24 months
Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure
MTD or RP2D of IBI3001 Number of subjects with dose-limiting toxicities (DLTs)
Time frame: 24 months
Dose limiting toxicity (DLT) to establish MTD or RP2D
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female participants ≥ 18 years old;
- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
- Has an anticipated life expectancy of ≥ 12 weeks;
- Adequate bone marrow and organ function:
- At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. for dose escalation , and 1 measurable lesion for dose expansion.
- Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available; participants who refuse standard therapy, or are able to suspend standard therapy without major risks. Key
Exclusion criteria
- Progressed or refractory to an ADC that consists of an Exatecan derivative that is a topoisomerase I inhibitor or intolerable with an ADC that consists of Exatecan;
- Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also not have an impact on tumor assessment throughout the study;
- Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours);
- Gastrointestinal perforation and/or fistula within 6 months prior to first administration of the study drug, and not recovered after surgical treatment;
- Known symptomatic central nervous system (CNS) metastases.
- History of pneumonia requiring corticosteroids therapy, or history of clinically significant lung diseases; Uncontrolled diseases;
- History of endotracheal or gastrointestinal stent implantation;
- Ascites, pleural effusion, or pericardial effusion with symptoms and requiring intervention;
- Esophageal or gastric varices requiring immediate intervention;
- Not eligible to participate in this study at the discretion of the investigator;
- Do not have adequate treatment washout period before study drug administration. -
Where
- Los Angeles, California
- East Brunswick, New Jersey
- Dallas, Texas
- Fairfax, Virginia
Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 25, 2026 · Source of record for eligibility and locations